Blood collection tube holder safety guard

ABSTRACT

A medical device particularly adpated for use with a blood collection tube including a nonlinear needle having first and second needle points wherein the first needle point is selectively protected by a movable protective shield and the second needle point is designed to pierce the stopper of an evacuated blood collection tube. The needle guard is movable axially along a portion of the nonlinear needle between a needle tip exposing retracted position and a needle covering locked extended position.

FIELD OF THE INVENTION

This invention relates to blood collection devices and more particularlyto a blood collection device having an extendable needle guard thereonfor preventing accidental needle sticks.

BACKGROUND OF THE INVENTION

The use of evacuated tubes for the collection of blood samples is wellknown. Conventional blood collection devices include a cylindricalcontainer or blood collection tube, a blood collection tube holder and adouble ended needle. The blood collection tube includes a closed bottomend and an open top end which is sealed by a needle-pierceable stopperor closure. The blood collection tube holder includes an elongate barrelsection, a proximal finger flange and a distal needle hub mountingsection.

In a conventional blood collection device, the evacuated bloodcollection tube is removably mounted in the elongate tubular bloodcollection tube holder. The distal end of the blood collection tubeholder includes a threaded hub section which releaseably engages thethreaded hub of the double-ended needle. The needle of the conventionalblood collection device is typically straight and includes distal andproximal needle sections wherein the distal section of the needle isdesigned to pierce the vein of the patient and the proximal section ofthe needle is designed to pierce the stopper of the evacuate collectiontube.

Typically, blood is withdrawn from a patient by first puncturing a veinwith one end of the double-ended needle and then, while firmly holdingthe blood collection tube holder, pushing the needle pierceable stopperof the blood collection tube against the other end of the needle untilthe stopper is pierced. After the desired volume of blood is drawn fromthe patient's vein into the blood collection tube, the needle iswithdrawn from the patient. In the conventional blood collection device,the needle is then removed from the blood collection tub holder anddiscarded. A new needle may then be threaded onto the blood collectiontube holder and the device is used to obtain another blood sample fromanother patient.

With the onset of AIDS and other infectious diseases, a variety ofdevices have been designed to decrease the likelihood that a health careworker will be infected by accidental contact with an infected needle.Even if the health care worker does not actually contract the diseasefrom the infected needle, a large amount of time and money is spent ontesting and counseling the health care worker every time the health careworker is inadvertently stuck by a potentially infectious needle.

U.S. Pat. No. 4,758,231, issued to Haber et. al. on July 19, 1988,discloses one approach to protecting the health care worker fromaccidental needle sticks. In the Haber device, a protective shieldsurrounds the blood collection tube holder while blood is being drawnfrom the patient. Once the final blood sample has been obtained, theshield is moved distally along the blood collection tube holder to anextended position wherein the distal end of the standard bloodcollection needle is covered by the protective shield.

Another approach is generally disclosed in U.S. Pat. No. 4,782,841issued to Lopez on Nov. 8, 1988 and U.S. Pat. No. 4,731,059 issued toWanderer et. al. on Mar. 15, 1988. In the Lopez and Wanderer devices, anelongated blood collection needle is used in combination with a bloodcollection tube holder and protective sleeve. The protective sleeve ofthe respective devices is mounted directly on the elongate distalsection of the needle. In the retracted position, the protective shieldexposes the distal end of the needle. In the extended position, theprotective shield is moved distally along the needle shaft until theprotective shield covers the distal end of the needle whereupon theproximal end of the protective sleeve engages a locking mechanismmounted on the needle shaft.

Although the above described devices satisfy the general requirementthat the distal end of the needle be protected by a movable shield, thecost of molding and assembling these devices would result in a finalproduct which is not affordable for many hospitals. Additionally, theprotective shield of the Haber device increases the outer circumferenceof the blood collection assembly so that the health care worker may havedifficulty carrying multiple blood collection devices on their tray andthe blood collection tube holder is not reusable. The devices disclosedin the Lopez and Wanderer patents require the use of an unusually longneedle in order to accommodate mounting the protective shield directlyon the distal section of the needle. This dramatically increases thecost of producing a device as disclosed in the respective patents. Allof the above described patents also require the health care worker touse both hands in order to extend the protective shield. In the Lopezand Wanderer patents, one of the hands of the health care worker must beplaced unacceptably close to the potentially infectious distal end ofthe needle in order to move the protective shield to the extendedposition.

U.S. Pat. No. 3,326,206 ('206 patent) issued to Barr et al on June 20,1967 and U.S. Pat. No. 3,520,292 ('292 patent) issued to Barr et al onJuly 4, 1970 are generally relevant to the present invention for thedisclosure of a blood sampling device having a curved needle generallyof the type contemplated by the present invention. The device disclosedin the '206 patent is designed to allow the needle to be mounted in orremoved from a needle holder without touching the needle. The bloodcollection device disclosed in this patent includes a slide elementwhich contacts and retains the needle in the needle holder while theblood collection device is in use and wherein the slide element ismovable to allow for the removal of the needle from the needle holder.The device illustrated in the '206 patent provides no protection againstaccidental needle sticks and may actually contribute to the incidence ofpotentially dangerous needle sticks by providing a device wherein theentire blood collection needle is designed to be removable from theneedle holder. The blood collection device illustrated in the '292patent utilizes a curved needle and a modified blood collection tubeholder. The '292 patent is directed to providing a blood collectiondevice having a removable distal end cap and a movable protectivediaphragm on the proximal end of the modified blood collection tubeholder to provide a blood collection device which is maintained in asterile condition during storage and transport. As with the '206 patent,the '292 patent provides no protection against accidental needle sticksand requires the use of a modified, non-reusable blood collection tubeholder.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an effectiveprotective shield for use with conventional blood collection tubes andholders.

It is a further object of the present invention to provide a relativelyinexpensive protective shield which provides the health care worker withprotection against accidental needle sticks and includes none of thedisadvantages mentioned above.

Another object of the present invention is to provide a blood collectionassembly wherein the protective shield may be extended or retracted witha single hand.

In accordance with one form of the present invention, an integral needlehousing is mountable on the distal end of a standard blood collectiontube holder so that the protective shield is generally aligned andmovable along a support member on the side of the blood collection tubeholder between retracted and extended positions. The needle housingincludes a nonlinear needle to provide communication between theevacuated blood collection tube and the vein of the patient.

The needle housing further includes a shield assembly consistinggenerally of a support member, a finger member and a protective shieldwherein the finger member and protective shield are slidable linearly inthe support member between a retracted position wherein the needle isexposed and an extended position wherein the needle is covered. Theshield assembly also includes a start detent on the support member thatallows the finger member and protective shield to be moved only in theproximal direction along the needle to expose the distal end of theneedle. In the initial start position, the distal end of the needle ispartially covered by the protective shield. As the protective shield ismoved proximally from the start position, the start detent is moved froma contacting relation with a start recess on the shield assembly to aneutralized position wherein the start detent is generally planar withthe interior surface of the support member.

When the protective shield and finger member are in the fully retractedposition, the blood sample may be taken by inserting the distal sectionof the needle into the vein of the patient and inserting a standardblood collection tube onto the proximal section of the needle. When asatisfactory blood sample has been obtained, the distal section of theneedle is withdrawn from the arm of the patient and the health careworker may simultaneously move the protective shield to the lockedextended position. Unlike previous blood collection devices, the presentinvention allows the health care worker to hold the blood collectionassembly and move the protective shield to the extended position bymerely placing their thumb on the finger means and moving the fingermeans distally until the protective shield assembly is moved to anextended locked position. Once this occurs, the protective shield willcover the distal section of the needle and may not be moved to theretracted position without the use of excessive force.

In other forms of the invention described herein, the distal end of theprotective shield assembly includes a reduced diameter distal opening tocompress the protective shield as it moves distally along the distalsection of needle. In another form of the invention, the distal end ofthe protective shield includes a pair of tabs thereon to limit theproximal movement of the protective shield to the fully retractedposition. In yet another form of the present invention described herein,the protective shield is slidable in a nonlinear manner between theextended and retracted positions. In all of the forms of the inventiondescribed above, it is readily anticipated that the present inventionmay be readily modified for use on nearly any medical or laboratorydevice having a needle thereon.

An advantage of the present invention is that it is relativelyinexpensive to manufacture and simple to use.

A further advantage of the present invention is that it offersconvenient single handed operation.

A further advantage of the present invention is that it usesconventional blood collection tubes and holders.

A further advantage of the present invention is that the use of thenonlinear needle allows for the convenient alignment of the needle withthe vein of the patient.

A further advantage of the present invention is that it allows thehealth care worker to reuse the conventional blood collection tubeholder.

A further advantage of the present invention is that it is compact andallows multiple blood collection devices to be placed on the health careworkers tray.

Yet another advantage of the present invention is that it does notrequire the health care worker to place their hand near the distalneedle point to move the protective shield to the extended position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the preferred embodiment of the presentinvention;

FIG. 2 is a side view, partially in cross-section of the preferredembodiment in the assembled condition;

FIG. 3 is a frontal view of the preferred embodiment partially incross-section;

FIG. 4A is a side view of the needle housing of the preferred embodimentillustrating the inside of the needle housing prior to assembly;

FIG. 4B is a top view of the needle housing illustrated in FIG. 4A;

FIG. 5 is a partial cross-sectional view of the preferred embodiment inthe retracted position;

FIG. 6 is a partial cross-sectional view of the preferred embodiment inthe extended position;

FIG. 7A is a side view of the shield assembly of the preferredembodiment;

FIG. 7B is a frontal view of the shield assembly of the preferredembodiment;

FIG. 8 is a perspective view of an alternate embodiment of the presentinvention;

FIG. 9 is an exploded perspective view of an alternate embodiment of thepresent invention;

FIG. 10 is a side view in cross-section, of the assembled alternateembodiment illustrated in FIG. 9 with the protective shield in the startposition;

FIG. 11 is a partial frontal view, partially in crosssection, of theassembled embodiment illustrated in FIG. 9;

FIG. 12 is a frontal view of the embodiment illustrated in FIG. 9 withthe protective shield in the extended position;

FIG. 13 is a frontal view of the shield assembly of the embodimentillustrated in FIG. 9;

FIG. 14 is a side view of the shield assembly and start detent of theembodiment illustrated in FIG. 9;

FIG. 15 is a perspective view of an alternate embodiment of the presentinvention;

FIG. 16 is a cross-sectional view of the embodiment illustrated in FIG.15 with the protective shield in the start position;

FIG. 17 is a enlarged cross-sectional view of the needle hub of theembodiment illustrated in FIG. 15 with the protective shield in theextended position;

FIG. 18 is a partial cross-sectional perspective view of an alternateembodiment of the embodiment illustrated in FIG. 15; and

FIG. 19 is a cross-sectional view of the protective shield of theembodiment illustrated in FIG. 18.

DETAILED DESCRIPTION OF THE INVENTION

In its preferred embodiment, the invention is intended to be used inconjunction with a conventional blood collection tube and holder;however, it is anticipated that the present invention may be modifiedfor use with nearly any medical or laboratory device; such as a syringe,without departing from the contemplated scope of the present inventionas defined by the claims attached hereto.

In describing the present invention, the term "distal end" of an elementrefers to the end of the element closest to the needle point of thedevice which is designed to pierce the skin of the patient. The term"proximal end" of an element refers to the end of the element furthestfrom the needle point which is designed to pierce the skin of thepatient. The terms "inner" or "inwardly" and "outer" or "outwardly" areused herein to refer to the orientation of an element with respect tothe reference plane designated as A--A in FIGS. 1 and 10. The referenceplane A--A extends generally through the central axis of the bloodcollection tube holder and along the proximal needle section.

As illustrated in the attached drawings, the present invention generallyincludes a blood collection device 10 consisting of a blood collectiontube (not shown), a blood collection tube holder 14 and a needle housing16. The blood collection tube described herein is a conventionalevacuated tube having a needle pierceable stopper thereon. The bloodcollection tube holder 14 described herein is a conventional bloodcollection tube holder consisting of a pair of proximal finger flanges(not shown), an elongate barrel section 20 and a preferably threadedneedle hub mounting section 22 positioned on the distal end of the bloodcollection tube holder 14.

In the preferred embodiment, the needle housing 16 preferably consistsof a foldable, one-piece molded element which may be molded asillustrated in FIGS. 4A and 4B and then folded and bonded around thenonlinear needle referred to here in as needle 24 to form the needlehousing 16 illustrated in FIG. 1. It is anticipated that the needlehousing 16 may also be formed by a pair of molded elements bondedtogether to retain the needle 24 therein. The needle housing 16 asillustrated in FIGS. 4A and 4B, includes a needle recess 18, a bondingsurface 19, a needle protecting lip 21 and a shield alignment lip 23.The needle recess 18 is located on each half of the needle housing 16 toretain the needle 24 therein in a fixed position. The bonding surface 19consists of a protrusion on one of the halves of the needle housing 16and a matching recess on the other half to irreversibly retain theneedle housing 16 in the assembly position. The needle protecting lip 21extends outwardly from the top of one half of the needle housing 16 inan overlapping manner into a corresponding recess on the opposing halfof the needle housing 16 to maintain the sterility of the needle 24 andto prevent access to the needle 24 when the needle housing 16 isassembled. The shield alignment lip 23 extends into the cylindricalshield support member 32 to contact the elongate slit 40 on theprotective shield 28 to prevent rotational movement of the protectiveshield 28 as it is moved between the retracted and extended positions.

The assembled needle housing 16 preferably includes the nonlinear needle24, a needle hub section 26, a shield support member 32 and a shieldassembly 27 consisting of a protective shield 28 and a finger member 30.The needle 24 of the present invention consists generally of a proximalneedle section 34 which is preferably straight and extends proximallybeyond the proximal end of the needle hub section 26 to a sharpenedproximal point 35; a curved intermediate needle section 36 is containedwithin the needle hub section 26 to create the preferred nonlinearorientation of the needle 24 and a distal needle section 38 which ispreferably straight and extends distally beyond the distal end of theneedle hub section 26. The proximal needle section 34 and the distalneedle section 38 of the needle 24 are preferably oriented in agenerally parallel and offset manner with respect to each other tofacilitate single handed operation of the present invention. The distalend of the needle 24 includes a bevelled distal needle point 39 orientedto facilitate the insertion of the distal needle section 38 into thevein of the patient. The proximal needle point 35 on the proximal end ofthe needle 24 is designed to pierce the stopper of a blood collectiontube once the proximal end of the needle hub section 26 has beenthreaded onto the hub mounting section 22 of the blood collection tubeholder 14.

The needle hub section 26 of the present invention preferably consistsof a separately molded element having a threaded section thereon tofacilitate the attachment of the blood collection tube holder 34thereto. The needle hub section 26 is preferably adhesively bonded orwelded to a recess on the inner, proximal side of the needle housing 16.

The protective shield 28 of the present invention preferably consists ofan elongate tubular member constructed of a semi-rigid polypropylenehaving a sufficient rigidity to protect against being deflected off thedistal needle section 38 while having sufficient flexibility to bepositioned along the length dimension of the distal needle section 38 inan overlapping or encircling manner. The protective shield 28 includesan elongate slit 40 extending proximally from the distal end thereof toa location approximately midway along the shield assembly 122 and a pairof radial tabs 41 near the distal end of the protective shield 28. Theproximal end of the shield assembly 27 includes the finger member 30which extends proximally from the proximal end of the protective shield28. The protective shield 28 and finger member 30 are slidably retainedin the shield support member 32 and are preferably positioned to slidein the shield support member 32 adjacent to the barrel section 20 of theblood collection tube holder 14. The protective shield 28 is furtheraxially aligned to slide along the distal needle section 38 of theneedle 24. Although the shield assembly 27 is preferably constructed asa two-piece molded or extruded element wherein the protective shield 28and finger member 30 are formed as separate elements which are thenassembled together with either a frictional fit, adhesives or nearly anyother convenient method of attachment, it is readily anticipated thatthe shield assembly 27 may also be formed as a single-piece molded orextruded element.

In this embodiment, a generally wedge-shaped start detent recess 42 ispositioned on the outer side of the shield support member 32 adjacent tothe proximal end of the protective shield 28. A needle recess (notshown) is located near the proximal end of the inner surface ofprotective shield 28 adjacent to the finger member 30. The needle recessis preferably an enlarged opening on the proximal end of the elongateslit 40 to allow the protective shield to enclose the proximal end ofthe distal needle section 38 when the protective shield 28 is in theextended position. A biased locking tab 46 is positioned on the innersurface of the shield assembly 27 on the finger member 30. The lockingtab 46 is biased inwardly from the finger member 30 to form a contactingrelation with a locking recess 48 located on the inner side surface ofthe shield support member 32 when the protective shield 28 is in thefully extended position.

The shield support member 32 of the shield assembly 27 includes anenclosed elongate groove or channel along the outer side of the needlehousing 16 to enclose a portion of the shield assembly 27 therein. Thedistal end of the shield support member 32 includes an enlarged recess43 to releasably retain the radial tabs 41 therein when the protectiveshield 28 is in the retracted position. The proximal end of the shieldsupport member 32 is semicircular and extends beyond the proximal end ofthe needle housing 16 to allow the shield assembly 27 to be slidablymoved therein a sufficient distance to allow the protective shield 28 toexpose the distal needle section 38 when the protective shield 28 ismoved to the retracted position. The groove or channel section of theshield support member 32 extends to the distal end of the needle housing16 to form a distal shield opening 62 which is adjacent to the enlargedrecess 43 and positioned generally at the intersection of theintermediate needle section 36 and the distal needle section 38.

A locking recess 48 is positioned approximately midway along the innerside surface of the shield support member 32 to retain the locking tab46 from the shield assembly 27 therein when the protective shield 28 isin the fully extended position. The outer side surface of the shieldsupport member 32 includes an inwardly biased start detent 50. The startdetent 50 is positioned in a side recess 52 on the needle housing 16.The proximal end of the start detent 50 preferably includes a pair ofcontacting lips 42 to frictionally contact the sides of the side recess52 to retain the start detent 50 in the neutralized position once theshield assembly 27 is moved proximally from the initial start position.

FIGS. 2 and 3 illustrate the blood collection device 10 of the preferredembodiment assembled for shipping and storage. The proximal end of theblood collection device 10 includes a rectangularly shaped proximal hardcase 56 which is preferably heat staked to the needle housing 16. Theproximal hard case 56 encloses and maintains the sterility of theproximal end of the shield assembly 27 and the shield support member 32during shipping and storage. A rubber needle sleeve 58 is alsopreferably positioned on the proximal needle section 34 to preventaccidental needle sticks when the proximal hard case 56 is removed andprior to the insertion of the proximal needle section 34 into the bloodcollection tube holder 14. Once the hub mounting section 22 of the bloodcollection tube holder 14 is threaded into the needle hub section 26 ofthe needle housing 16, the elongate barrel section 20 of the bloodcollection tube holder 14 protects the user from accidentally contactingthe proximal needle point 35 of the proximal needle section 34. Thedistal end of the blood collection device 10 includes a distal hard case60 which is heat staked to the distal end of the needle housing 16. Thedistal hard case 60 encloses and maintains the sterility of the distalneedle section 38 and protects the distal needle point 39 duringshipping and storage.

When the health care worker desires to obtain a blood sample from apatient, the health care worker initially applies lateral pressure tothe proximal hard case 56 to break the heat stake on the needle housing16. Next, the blood collection tube holder 14 is threaded onto theneedle hub section 26 of the needle housing 16. Once the appropriatesite on the patient's arm has been prepared, the health care worker mayremove the distal hard case 60 from the needle housing 16 by rotatingthe distal hard case 60 until the heat stake is broken.

Next, the health care worker moves the shield assembly 27 from the startposition wherein the protective shield 28 substantially encloses thedistal needle section 38 to the retracted position by placing theirthumb on the finger member 30 to move the finger member 30 proximallyalong the shield support member 32 until the distal needle section 38 isuncovered by the protective shield 28. As the shield assembly 27 ismoved proximally along the shield support member 32, the protectiveshield 28 and the elongate slit 40 are moved over the distal portion ofthe intermediate needle section 36 and the distal needle section 38. Thestart detent 50 is also moved from an initial start position in thestart detent recess 42 to a neutralized position wherein the contactinglips 54 of the start detent 50 frictionally contact the sides of theside recess 52 to create a generally planar relation along the interiorsurface of the shield support member 32 so that the start detent 50 doesnot interfere with any further movement of the shield assembly 27 in theshield support member 32. The shield assembly 27 is moved proximally inthe shield support member 32 until the radial tabs 41 reach the enlargedrecess 43 which prevents further proximal movement of the shieldassembly 27 in the shield support member 32. Once the shield assembly 27is in the retracted position, the blood collection device 10 and thedistal needle section 38 of the needle 24 may then be aligned parallelto the vein of the patient so that the bevelled end of the distal needlepoint 39 is adjacent to the skin of the patient.

The distal needle section 38 of the needle 24 is then inserted into thevein of the patient and an evacuated blood collection tube is insertedinto the blood collection tube holder 14. As the blood collection tubeis inserted into the blood collection tube holder 14, the stopper of theblood collection tube contacts the rubber needle sleeve 58 and causesthe proximal needle point 35 to pierce the rubber needle sleeve 58. Thestopper then compresses the rubber needle sleeve 58 against the needlehub section 26 of the needle housing 16 as the blood collection tube ispushed into the blood collection tube holder 14.

Once the proximal needle section 34 passes through the stopper of theblood collection tube, blood is drawn from the vein of the patient intothe evacuated blood collection tube. When a sufficient blood sample hasbeen obtained from the patient, the blood collection tube is removedfrom the blood collection tube holder 14 and the rubber needle sleeve 58resiliently covers the proximal needle section 34. If a further bloodsample is desired, a second blood collection tube may be inserted intothe blood collection tube holder 14 and the blood collection procedureis repeated.

Once a sufficient number of blood samples have been obtained and thefinal blood collection tube has been removed from the blood collectiontube holder 14, the health care worker may remove the distal needlesection 38 of the needle 24 from the vein of the patient. Immediatelyafter the distal needle section 38 of the needle 24 has been removedfrom the vein of the patient, the health care worker may single handedlyhold the blood collection device 10 and move the finger member 30distally along the shield support member 32 until the protective shield28 encloses the distal needle section 38 and the distal needle point 39of the blood collection device 10. As the finger member 30 andprotective shield 28 are moved distally along the shield support member32, the inwardly biassed locking tab 46 will frictionally contact theinner surface of the shield support member 32 until the locking tab 46reaches the locking recess 48 on the inner surface of the shield supportmember 32 when the protective shield 28 reaches the fully extendedposition. The locking tab 46 and locking recess 48 are located in anenclosed portion of the needle housing 16 to prevent access to thelocking mechanism of the present invention so that the locking mechanismcannot be defeated unless extraordinary force is used.

FIG. 8 illustrates an alternate embodiment of the present inventionwherein the shield support member 32 includes a reduced diameter section64 to compress the protective sheath 28 around the distal needle section38 as the protective sheath is moved distally from the retractedposition to the extended position As illustrated, the reduced diametersection 64 is positioned at the distal shield opening 62 on the needlehousing 16 and adjacent to the intersection of the intermediate needlesection 36 and the distal needle section 38 to compress the protectiveshield 28 after the needle 24 has passed through the elongate slit 40.This embodiment provides additional protection against needle stickscaused by accidental deflection of the protective shield 28 off thedistal needle section by causing the sides of the protective shield 28to overlap once the protective shield 28 passes distally beyond thereduced diameter section 64.

FIG. 8 illustrates yet another feature of the present invention whereinthe protective shield 28 includes a distal notched section 66 to assistin aligning the needle 24 with the elongate slit 40 and a modifiedshield support member 32'. In this embodiment, the protective shield 28is moveable to a retracted position wherein the notched section 66 ofthe protective shield 28 is spaced apart from the needle 24 apredetermined distance The radial tabs 41 on the distal end of theprotective shield 28 contact the enlarged recesses 67 on the distal endof the needle housing 16. This allows the health care worker to visuallyobserve the entire distal needle section 38 of the needle 24 prior to orduring the insertion of the needle into the patient while the protectiveshield 28 is in the retracted position. The modified shield supportmember 32' is shorter than the shield support member 32 of the previousembodiment and functions as a guide and locking means for the shieldassembly 27 in the same manner as described above for FIGS. 1-7.

Another form of the present invention is illustrated in FIGS. 9-14. Inthis embodiment, the needle housing 110 consists of a pair of preferablymolded elements which may be snap fit or adhesively bonded together toretain the nonlinear needle referred to herein generally as needle 124in a sterile, fixed position within the needle housing 110. The needlehousing 110 of this embodiment consists generally of a needle cover 112,a needle platform 114, a shield assembly 127 and a nonlinear needle 124.As with the first embodiment, the needle 124 of the present embodiment,consists of a generally straight proximal needle section 134, a curvedintermediate needle section 136 and a generally straight distal needlesection 138. The proximal end of the proximal needle section 134 and thedistal end of the distal needle section 138 include bevelled needlepoints, 135 and 139, respectively.

The needle platform 114 of the present embodiment includes a threadedneedle hub section 125, a generally flat platform surface 116, a shieldlocking section 118, and an angled needle positioning surface 120. Theneedle hub section 125 extends proximally along the inner side of theflat platform surface 116 and includes a threaded proximal section andhub thereon to facilitate the attachment of a standard blood collectiontube holder 14 and rubber needle sleeve 164 thereto. The shield lockingsection 118 extends proximally from the outer side of the flat platformsurface 116 to frictionally contact the shield assembly 127. The shieldlocking section 118 consists of a semi-circular extension having a pairof inwardly biased locking detents 122 on the sides thereof and a rampedstart detent recess 123 on the inner surface thereof. The angledpositioning surface 120 is a quadrilaterally shaped element whichextends distally from the center of the platform surface 116 betweenneedle hub section 126 and the shield locking section 118. The sides ofthe angled positioning surface 120 include a pair of cover retainingtabs 126 extending outwardly therefrom. The top surface of the angledpositioning surface 120 is angled to match the general angle of theintermediate needle section 136 of the needle 124 and includes a needlegroove 128 to retain the intermediate needle section 136 of the needle124 therein.

The needle cover 112 is preferably a molded element which encloses andretains the intermediate needle section 136 of the needle 124 in a fixedposition. The outer side of the needle cover 112 includes a cylindricalshield support cylinder 130 which slidably encloses and retains theshield assembly 127 therein The sides of the needle cover 112 include apair of tab retaining slots 132 which irreversibly retain the tabs 126from the needle platform 114 therein. A perimeter flange 140 is locatedalong the proximal surface of the needle cover 112. The perimeter flange140 is spaced slightly above the proximal end of the needle cover 112 toprovide support for the proximal hard case 156 which is preferably heatstaked thereto.

The shield assembly 127 is generally a rigid elongate tubular elementhaving a distal section 142 and a proximal section 144. The distalsection 142 of the shield assembly 127 includes an elongate needle slot146 extending the entire length of the distal section 142. The distalend of the needle slot 146 includes a notched section 148 to facilitatethe passage of the needle 124 into the needle slot 146 and a pair ofradial tabs 141 to limit the proximal movement of the shield assembly127. The proximal section 144 of the shield assembly 127 includes astart detent 148, a start detent slot 150 and a pair of shield lockingrecesses 152 thereon. The start detent slot 150 is located on the innersurface of the shield assembly 127. The start detent 148 is a generallywedge shaped, moveable element having its proximal end hingedlypositioned on the outer surface of the shield assembly 127. The distalend of the start detent 148 includes a positioning tab 154 thereon whichis angled inwardly to releasably project through start detent slot 150and into the start detent recess 123 on the platform surface 116 in theinitial assembled position The shield locking recesses 152 arepositioned proximal to the start detent 148 and form a pair of generallywedge shaped recesses on the outer proximal surface of the shieldassembly 127. The proximal end of the shield assembly 127 forms a fingerpad 158 to facilitate the single handed operation of the presentembodiment.

Assembly of this embodiment is relatively simple and may be accomplishedquickly and inexpensively. Initially, the intermediate needle section136 of the needle 124 is positioned in the needle groove 138 so that theproximal needle section 134 of the needle 124 extends through thethreaded proximal section of the platform surface 116. The needle 124may be adhesively bonded or welded to any convenient surface of theplatform surface 116 to retain the needle 124 therein The needle cover112 is then snapped onto the platform surface 116 so that the retainingtabs 126 extend through the retaining slots 132 to retain the needlecover 112 on the platform surface 116 and the distal needle section 142extends through the shield support cylinder 130. The rubber needlesleeve 164 is then placed on the proximal needle section 134 and theshield assembly 127 is inserted into the shield support cylinder 130 onthe needle cover 112.

The start detent 148 is then pressed inwardly as the shield assembly 127is moved distally through the shield support member 130. The shieldassembly 127 slides distally through the shield support member 130 untilthe positioning tab 154 on the start detent 148 passes through the startdetent slot 150 and contacts the start detent recess 123 on the shieldlocking section 118 of the needle platform 114. In this position, thedistal section 142 of the shield assembly 127 partially encloses thedistal needle section 138 and is prevented from further distal movementby contact between the positioning tab 154 on the start detent 148 anddistal side of the start detent recess 123. Finally, the proximal hardcase 156 and the distal hard case 160 are heat staked to the respectiveends of the assembly. Once the device has been sterilized, it may thenbe shipped and stored without losing sterility.

The present embodiment operates similar to the first embodimentdescribed above for FIGS. 1-7. When the health care worker desires toobtain a blood sample from a patient, the health care worker may applylateral pressure to the proximal hard case 156 to break the heat stakebetween the proximal hard case 156 and the perimeter flange 140. Next,the blood collection tube holder 14 is threaded onto the needle hubsection 125. Once the appropriate site on the patients arm has beenprepared, the health care worker may remove the distal hard case 160from the needle housing 110 by rotating the distal hard case 160 untilthe heat stake on the distal end of the needle cover 112 is broken.

The health care worker may then move the shield assembly 127 from theinitial start position to the retracted position by placing their thumbon the finger pad 158 and moving the shield assembly 127 proximallyalong the shield support member 130. As the shield assembly 127 is movedproximally along the shield support member 130, the start detent 148 ismoved from the start detent recess 123 and the start detent slot 150 toa neutralized position on the shield assembly 127. A pair ofsupplemental detents 162 on the interior surface of the shield assembly127 prevent the start detent 148 from returning to the initial startposition. Once the shield assembly 127 is moved to the retractedposition, the blood collection device 10 and the distal needle section138 of the needle 124 may be aligned parallel to the vein of the patentso that the distal needle point 139 is adjacent to the skin of thepatient.

Next, the distal needle section 138 of the needle 124 is inserted intothe vein of the patient and an evacuated blood collection tube isinserted into the blood collection tube holder 14. As the bloodcollection tube is inserted into the blood collection tube holder 14,the stopper of the blood collection tube contacts the rubber needlesleeve 164 and causes the proximal needle point 135 to pierce the rubberneedle sleeve 164. The stopper then compresses the rubber needle sleeve164 against the needle hub section 125 of the needle housing 110 whilethe stopper is pierced by the proximal needle point 135.

Once the stopper is pierced by the proximal needle point 135, blood isdrawn from the vein of the patient into the evacuated blood collectiontube 12. When a sufficient amount of blood has been obtained, the bloodcollection tube 12 is removed from the blood collection tube holder 14and the resilient rubber sleeve recovers the proximal needle point 135.If a further blood sample is desired, a second blood collection tube 12may be inserted into the blood collection tube holder 14 and the bloodcollection procedure is repeated.

Once a sufficient number of blood samples have been obtained and thefinal blood collection tube 12 has been removed from the bloodcollection tube holder 14, the health care worker may remove the distalneedle section 138 from the vein of the patient. Immediately afterremoving the needle 124 from the vein of the patient, the health careworker may single handedly hold the blood collection device 10 and movethe finger pad 156 distally along the shield support member 130 untilthe distal section 152 of the shield assembly 127 encloses the distalneedle section 138 and distal needle point 139 of the blood collectiondevice 10. As the shield assembly 127 is moved distally along the shieldsupport member 130, the locking detents 122 will be biased against sidesof the shield assembly 127 until the locking detents 122 reach thelocking recesses 152 on the proximal section 144 of the shield assembly127. When the shield assembly 127 is in the locked extended position,the cooperation between the locking detents 122 and the locking recesses152 will prevent the shield assembly 127 from being retracted unlessexcessive force is applied to the shield assembly 127.

FIGS. 15-19 illustrate yet another form of the present invention whereinthe protective shield 70 is slidable in a nonlinear manner along apreferably straight needle 72.

In this embodiment, the blood collection tube holder 74 and the proximalneedle section 76 are preferably the same as the blood collection tubeholder 14 and the proximal needle section 34 described above. Asillustrated in FIG. 16, the needle hub section 78 is threadedly mountedon the distal end of the blood collection tube holder 74 and includes anoffset protective shield passageway 80 through which the protectiveshield 70 is moved between the retracted and extended positions. Thedistal end of the needle hub section 78 preferably includes a reduceddiameter section 82 to compress the protective shield 70 as it passesfrom the protective shield passageway 80 onto the distal needle section84 of the needle 72.

The protective shield 70 of the present invention is preferablyconstructed of a semi-rigid polypropylene having sufficient rigidity toadequately protect the needle while having sufficient flexibility topass nonlinearly through the protective shield passageway 80. The distalend of the protective shield 70 includes a hardened tip 86 to protectthe health care worker from accidental needle sticks. As illustrated inFIG. 17, the hardened tip 86 includes a needle hole 88 and a flexiblelip 90 thereon. The proximal end of the protective shield 70 includes afinger member 92 thereon to facilitate the movement of the protectiveshield 70 between the retracted and extended positions. The elongateslit 94 of this embodiment extends between the hardened tip 86 and thefinger member 92 to allow the protective shield 70 to pass over theproximal end of the distal needle section 84.

When the protective shield 70 is in the retracted position, the hardenedtip 86 is positioned on the proximal end of the distal needle section 84immediately adjacent to the distal end of the needle hub section 78while the finger member 92 extends proximally from the proximal side ofthe protective shield passageway 80. As the protective shield 70 ismoved to the extended position, the hardened tip 86 moves distally alongthe distal needle section 84 and the elongate slit 94 of the protectiveshield 70 is opened as it passes over the proximal end of the distalneedle section 84. Once the elongate slit 94 has passed over theproximal end of the distal needle section 84, the reduced diametersection 82 of the needle hub section 78 compresses the elongate slit 94to cause the sides of the protective shield to overlap once they havepassed beyond the needle hub section 78.

In the extended position, the hardened tip 86 extends beyond the distalpoint 96 a sufficient distance to allow the flexible lip 90 to preventthe distal needle point 96 from returning through the needle hole 88.The finger member 92 on the proximal end of the protective shield 70 ispositioned adjacent to the proximal end of the protective shieldpassageway 80 and cannot be retracted unless extraordinary force is usedto force the distal needle point 96 through the flexible lip 90 and intothe needle hole 88 of the hardened tip 86. In another form of thepresent embodiment, the finger member 92 is movable into an enlargedarea (not shown) in the proximal end of the protective shield passageway80 so that the finger member is substantially flush with the proximalend of the protective shield passageway 80 in the extended portion.

FIGS. 18 and 19 illustrate yet another alternate form of the protectiveshield 70 of FIG. 15, wherein the respective sides of the protectiveshield 70' are oriented in an interlocking relationship once theprotective shield 70' pass beyond the proximal end of the distal needlesection 84.

The foregoing is intended to be descriptive of the preferred form of thevarious embodiments described above. It is readily anticipated thatcertain features of the embodiments are interchangeable or may bemodified without departing from the scope of the invention which isdefined by the following claims.

What is claimed is:
 1. A medical device, comprisingan elongate andnonlinear needle having a skin piercing needle point on one end thereof,a protective shield operatively associated with at least a portion ofsaid needle and adapted to be slidable along at least a portion of saidneedle between a needle point exposing position and a needle pointprotecting position wherein more of said protective shield protects saidneedle in the needle point protecting position than in the needle pointexposing position.
 2. The medical device of claim 1, wherein saidprotective shield includes distal and proximal sections and said distalsection is movable linearly along at least a portion of said needle. 3.The medical device of claim 1, wherein said needle includes first andsecond needle sections which are oriented generally parallel to eachother and wherein said protective shield includes a distal shieldsection which is movable linearly along at least a portion of said firstneedle section.
 4. The medical device of claim 3, wherein said needlefurther includes an intermediate needle section wherein saidintermediate needle section is nonlinearly oriented with respect to theorientation of said first and second needle sections.
 5. A medicaldevice, comprisingan elongate nonlinear needle having distal andproximal ends and first and second needle sections and a skin piercingfirst needle point on said distal end of said first needle section, aprotective shield operatively associated with said needle and adapted tobe movable between a first needle point exposing position and a firstneedle point protecting position wherein at least a portion of saidprotective shield protects said needle only in the first needle pointprotecting position, a tube holding member which removably receives anevacuated tube having a sealed end in said tube holding member, and saidsecond needle section being adapted to extend into at least a portion ofsaid tube holding member and being further adapted to penetrate thesealed end of the evacuated tube upon insertion of the evacuated tubeinto the tube holding member.
 6. The medical device of claim 5, whereinsaid needle is removably attachable to said tube holding member by hubmember which is adapted to releasably receive said tube holding memberthereon.
 7. The medical device of claim 6, wherein said first and secondneedle sections are oriented generally parallel to each other and saidhub member encloses an intermediate needle section between said firstand second needle sections.
 8. A medical device comprisingan elongateneedle having a distal needle point thereon and an elongate protectiveshield wherein one of said needle or protective shield is nonlinear withrespect to the other of said needle or protective shield which isgenerally linear and wherein said protective shield is operativelyassociated with said needle and adapted to be moved between a retractedposition wherein said distal needle point on said needle is exposed andan extended position wherein said distal needle point is protected andwherein more of said needle is protected by said protective shield inthe extended position than in the retracted position.
 9. The medicaldevice of claim 8, wherein said needle is nonlinear and includes a firstneedle section with a distal portion having said distal needle pointthereon and a proximal portion and said protective shield is an elongateand linear member which is oriented along said needle such that more ofsaid protective shield extends proximally of said proximal needleportion in the retracted position than in the extended position.
 10. Themedical device of claim 8, wherein said protective shield is nonlinearand movable along at least a portion of said linear needle and whereinmore of said protective shield extends proximally of a first needlesection of said needle having said distal needle point thereon in theretracted positioned than in the extended position.
 11. The medicaldevice of claim 8, wherein a locking means is operatively associatedwith said protective shield to prevent the movement of said protectiveshield to the retracted position once said protective shield has beenmoved to the extended position.
 12. The medical device of claim 8,wherein an elongate barrel shaped member is attachable adjacent the endof said needle opposite said distal needle point and wherein saidprotective shield is movable linearly along and adjacent to said barrelmember as said protective shield is moved from the retracted position tothe extended position.
 13. The medical device of claim 8, wherein anelongate barrel shaped member is attachable adjacent the end of saidneedle opposite said distal needle point and wherein said protectiveshield is movable in a nonlinear manner with respect to the longitudinaldimension of said barrel member as said protective shield is moved fromthe retracted position to the extended position.
 14. A medical device,comprisinga first needle section having a skin piercing first needlepoint thereon, a second needle section having a stopper piercing secondneedle point thereon, a hub member having said first and second needlesections mounted nonlinearly thereon, and a protective shield slidablymounted along said hub member and adapted to be moved between a firstneedle point exposing position and a first needle point protectingposition wherein more of said protective shield protects said needle inthe needle point protecting position than in said needle point exposingposition.
 15. The medical device of claim 14 wherein said first andsecond needle sections are mounted on said needle hub in a coplanarorientation.
 16. A medical device comprisingan elongate nonlinear needlehaving generally parallel first and second needle sections, a skinpiercing first needle point on said first needle section, a stopperpiercing second needle point on said second needle section, a hub membersubstantially enclosing an intermediate needle section of said needleand said intermediate needle section being positioned in fluidcommunication with said first and second needle sections, a bloodcollection tube holder releasably attached to said hub member at a firstend and having an open second end, a blood collection tube having astopper thereon and wherein said blood collection tube is insertableinto said second end of said blood collection tube holder so that saidsecond needle point pierces the stopper of said blood collection tube,an elongate protective shield slidably mounted on said hub member andadapted to be movable along said hub member between a retracted positionwherein said first needle point is exposed and an extended positionwherein said first needle point is protected such that more of saidprotective shield protects said needle in the extended position than inthe retracted position, and a locking means operatively associated withsaid protective shield to retain said protective shield in the extendedposition.
 17. The medical device of claim 16, wherein said protectiveshield has distal and proximal ends and said distal end includes atleast one tab means thereon to contact said hub member when saidprotective shield is in the retracted position and wherein said proximalend of said protective shield is oriented adjacent said blood collectiontube holder when said protective shield is in the retracted position.18. A medical device comprisingan elongate needle having first andsecond needle sections and a skin piercing needle point on said firstneedle section, a hub member enclosing at least a portion of said needlebetween said first and second needle sections, a blood collection tubeholder releasably attached to said hub member at one end and open at theother end, a blood collection tube having a stopper thereon wherein saidsecond needle section pierces the stopper on said blood collection tubewhen said blood collection tube is inserted into said other end of saidblood collection tube holder, and a protective shield slidably mountedalong said hub section wherein said protective shield is movable in anonlinear manner with respect to said first needle section between aretracted position wherein said needle point is exposed and an extendedposition wherein said needle point is covered and wherein at least aportion of said protective shield moves linearly along said first needlesection between the retracted and extended positions and wherein more ofsaid protective shield protects said needle in the extended positionthan in the retracted position.
 19. A medical device, comprisinganelongate and nonlinear needle including a first needle section havingdistal and proximal portions with a skin piercing needle point on thedistal portion thereof; a hub member connected to at least a portion ofsaid needle; a protective shield slidably supported by at least aportion of said hub member, said protective shield having distal andproximal ends and being adapted to be slidably moved between a retractedposition wherein said needle point is exposed and an extended positionwherein said needle point is protected by said distal end of saidprotective shield such that more of said protective shield protects saidfirst needle section in the extended position than in the retractedposition.
 20. The medical device of claim 19 wherein said proximal endof said protective shield extends proximally from said proximal portionof said first needle section in the retracted position.
 21. The medicaldevice of claim 19 wherein said hub member includes a locking meansoperatively associated therewith to retrain said protective shield inthe extended position.
 22. The medical device of claim 19 wherein saidhub member includes a retaining means operatively associated therewithto releasably retain said protective shield in an initial positionwherein said needle point is exposed.
 23. The medical device of claim 19wherein said protective shield is slidably supported in a passageway insaid hub member and said protective shield slides linearly between theretracted and extended positions.
 24. A method of obtaining a bloodsample from a patient comprisingorienting a medical device having a hubmember with first and second nonlinearly oriented needle sectionsextending from opposite ends thereof such that a first needle point onthe first needle section is aligned with the blood vessel of a patient;piercing the blood vessel of a patient with the first needle point;inserting a tubular member on the medical device such that a secondneedle point on the second needle section pierces a stopper on thetubular member to obtain a blood sample from the patient therein;withdrawing the first needle point from the blood vessel of the patient;and moving a protective shield which is slidably mounted along the hubmember from a retracted position wherein the first needle point isexposed to an extended position wherein the first needle point isprotected so that more of the protective shield protects the needle inthe extended position than in the retracted position.
 25. The method ofclaim 24 further including moving the protective shield from an initialstart position wherein the first needle section is substantiallyenclosed by the protective shield to the retracted position prior topiercing the blood vessel of the patient with the first needle point.26. The method of claim 24 further including locking the protectiveshield in the extended position so that the first needle point isprotected by the protective shield.